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Positive Airway Pressure System(PAP System)
EUDAMEDClass IIa (EU MDR)
Ref iBreeze 20AModel iBreeze 20C, iBreeze 20A
Identity
- Trade Name
- Positive Airway Pressure System(PAP System) EUDAMED
- Device Name
- Positive Airway Pressure System(PAP System) EUDAMED
- Model / Reference
- iBreeze 20C, iBreeze 20A EUDAMEDiBreeze 20A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970819423038 EUDAMED
- Basic UDI-DI
- 697081942iBreeze20CZ5 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Positive Airway Pressure System(PAP System) by Resvent Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697081942iBreeze20CZ5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Resvent Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012608
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9591f1d5-0eb4-428b-b084-c0458f8c4ec7 61 fields · synced Jun 18, 2026